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What Pharmacists Need to Know About Limbrel

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  • What Pharmacists Need to Know About Limbrel

    The FDA is investigating the medical food product for serious adverse effects. A pharmacist can convey this information to patients.

    What Pharmacists Need to Know About Limbrel

    NOVEMBER 27, 2017
    The FDA is recommending that patients immediately stop using medical food product Limbrel and contact their health care providers, as anyone taking the capsules is at risk for serious adverse effects.1 Pharmacists can play a key role in identifying osteoarthritis patients taking Limbrel to convey this important information. It is also important for health care professionals to report any adverse effects associated with Limbrel to the FDA?s Medwatch Safety Information and Adverse Event Reporting Program

    The FDA said that it is investigating Limbrel for the risk of life-threatening adverse effects, after receiving 194 adverse-event reports regarding the prescription capsules.1 Of these reports, 57 of the cases contained sufficient information to evaluate whether Limbrel was associated with an adverse event.1 Additionally, 30 of the 57 cases contained adequate information to use a causality assessment method to determine the likelihood of an association between Limbrel and the adverse effects.1 The FDA contacted Primus Pharmaceuticals, the manufacturer of Limbrel, regarding the adverse events and requested the formula information for further review and said that it will provide future updates....
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